Integrated multi-function endoscopic tool

ABSTRACT

A system for extending the visual capabilities and working channel of a bronchoscope including a probe having optic and/or tracking capabilities at a distal tip thereof and capable of being advanced through the working channel of a standard bronchoscope. The probe also includes a working channel through which various diagnostic and treatment tools may be advanced.

RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 13/474,572, filed May 17, 2012, which is adivisional of U.S. patent application Ser. No. 12/501,330 filed Jul. 10,2009 entitled Integrated Multi-Functional Endoscopic Tool, which claimsbenefit of U.S. Provisional Application Ser. No. 61/079,678, filed Jul.10, 2008 entitled Integrated Multi-Functional Endoscopic Tool; each ofwhich are hereby incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

Identifying and treating lung tissue abnormalities presents challengesthat are somewhat unique to the lungs. If a tissue lesion or tumor is tobe identified and excised surgically, the chest wall must be opened toprovide access to the lungs. Opening the chest wall is a commonprocedure but one that presents risks of infection and lengthy recoverytime, nonetheless. If a tissue lesion or tumor is to be identifiedendoscopically, the complicated bronchial maze must be navigated.

Bronchoscopes are small cameras attached to the end of a navigable probeand are useful in navigating the airways. The live, illuminated imagesprovide the physician a direct look at the inside surfaces of theairways; however, these bronchoscopes have some inherent shortcomings.First, their present size limits how far into the airways they can benavigated. The airways decrease in diameter as the alveoli areapproached. Second, the lungs are a moist environment and can cause thecamera lens to become obscured with moisture. Similarly, if a tissueprocedure, such as a biopsy, is performed in an airway that canaccommodate an endoscope and a cutting tool, there is a chance thatblood, mucous, or tissue may land on the lens and obscure thephysician's view.

To address the first shortcoming, technology has been developed thatallows a physician to track, in real-time, the position of a probe(hereinafter “locatable guide” or “LG”) traveling through the airways.This technology incorporates a plurality of coils at the end of an LGand a magnetic field generator outside of the patient. The patient isplaced in the magnetic field created by the generator. As the LG isnavigated through the airways, electrical current is induced in thecoils and sent via conductors to a computer. The computer can calculatethe position and orientation of the probe based on the relativestrengths of the current being induced. This technology is shown anddescribed in greater detail in U.S. Pat. Nos. 7,233,820 6,226,543,6,188,355, 6,380,732, 6,593,884, 6,711,429, 6,558,333, 6,887,236,6,615,155, 6,574,498, 6,947,788, 6,996,430, 6,702,780, and 6,833,814;and U.S. Patent Publications 20050171508, 20030074011, 20020193686, eachof which is incorporated by reference herein in its entirety and alsoPCT application WO 03/086498 titled ‘Endoscope Structure and Techniquesfor Navigation in Brunched Structure’ to Gilboa, fully incorporatedherein by reference.

These references describe a method and apparatus in which a thinlocatable guide, enveloped by a sheath, is used to navigate abronchoscopic tool to a target location within the lung, aimed inparticular to deliver treatments to the lung periphery beyond thebronchoscope's own reach. The coordinates of the target arepredetermined based upon three-dimensional CT data. A location sensor isincorporated at the locatable guide's tip. The enveloped guide isinserted into the lung via the working channel of a bronchoscope. First,the bronchoscope's tip is directed to the furthest reachable location inthe direction of the target. Next, the guide is advanced beyond the tipof the bronchoscope towards the designated target, based on thecombination of the CT data and the position of the guide's tip asmeasured in body coordinates. When the guide's tip is at the target, theguide is withdrawn, freeing the sheath for insertion of a bronchoscopictool. In order to prevent the distal end portion of the sheath fromsliding away from the target, the sheath is locked to the bronchoscope'sbody and the bronchoscope itself is held steadily to prevent it fromslipping further into the lungs or outwards. Because the airways in theperiphery of the lung are narrow, approximately in the same dimensionsas the sheath, sideways movements are extremely limited.

The above system and apparatus are aimed to navigate standardbronchoscopic tools to a target located in the lung. In its basicoperation, first the target is identified in the CT data, then the guideis navigated to the target and a medical treatment is delivered. Itwould be advantageous, however, to perform more sophisticatedtreatments, such as by combining different types of treatments into asingle session. Because these locatable guides are smaller thanendoscopes, they can travel deeper into the airways. Additionally,rather than relying on visible landmarks and the physician's knowledgeof the anatomy of the airways, the position of the LG is superimposed ona computer rendering or x-ray image of the lungs, thereby increasing thenavigation value of the sensor. Advantage may be taken of bothtechnologies by placing a probe within a working channel of theendoscope. Thus, real-time images may be viewed while navigating theendoscope as far into the airways as its size allows. Then, the LG isadvanced out of the distal end of the working channel of thebronchoscope and deeper into the airways. The LG is surrounded by asheath. In some embodiments the sheath is steerable and in others, theLG itself is steerable.

Once the LG has been navigated to a target area, presently the LG isretracted through the sheath, while the sheath is left in place. Thesheath is referred to as an “extended working channel” (“EWC”) becauseit is effectively an extension of the working channel of thebronchoscope. The EWC is then used as an avenue for inserting workingtools to the target site. Such tools include biopsy needles, ablationdevices, etc. After the LG is removed from the EWC, the physician isoperating blind, relying on the EWC to remain fixed at the target site.If a tool, such as an aspiration needle or an ablation tool, is beingused that requires repositioning in order to treat a greater targetarea, the repositioning must be done without guidance.

There is a need for an apparatus that allows a physician to operate on atarget site endoscopically, while benefiting from the concurrent use ofa bronchoscope, an LG, or both. There is a further need for anendoscopic tool that has the capability of maintaining a clear lensduring a procedure in a moist environment.

SUMMARY OF THE INVENTION

The present invention represents a step forward in endoscopic proceduresby providing an endoscopic tool that is capable of being inserted intonarrow passageways and performing procedures once a target has beenreached. Preferably the instrument of the present invention isinsertable through the working channel of a standard bronchoscope.

More specifically, the present invention is a catheter designed to beextended out of the distal end of the working channel of a bronchoscope.The catheter includes a micro-camera with a means for cleaning the lensthereof in situ. Additionally, the catheter includes a location sensorcapable of either transmitting a location signal or detecting locationfields such that location and orientation data may be provided to thepractitioner.

Additionally, the catheter of the present invention includes one or moreminiature working channels capable of receiving diagnostic andtherapeutic tools and catheters, such as biopsy or ablation tools andcatheters. Other examples of diagnostic and therapeutic tools for usewith the device of the present invention include various needles,forceps, guide catheters, cyrocatheters, needle aspiration catheters,modified atherectomy devices, just to name a few. The combination of thecamera, the miniature working channel, and the sensor, provides thepractitioner with a real-time view of the tissue being manipulatedduring the procedure. The practitioner also has an unprecedented degreeof confidence that the tissue being manipulated is the targeted tissue.

One aspect of the present invention uses the devices of the presentinvention for applications such as integrated in situ diagnostictechniques (AF, ULS, OCT, etc.), delivering pre-therapy tools to directsubsequent therapeutic procedures such as markers to guide radiosurgeryor inject dye to direct VATS procedures, therapeutic delivery such asLDR brachy seeds or site-specific drug delivery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a general embodiment of the device ofthe present invention;

FIG. 2 is a diagram of the basic components of an embodiment of thelocation system of the present invention;

FIG. 3 is an elevation of an embodiment of a sensor assembly of thepresent invention;

FIG. 4A is a perspective view of an embodiment of a sensor assembly ofthe present invention;

FIG. 4B is a circuit diagram of the sensor assembly of FIG. 4A;

FIG. 5 is a perspective view of an embodiment of a sensor assembly ofthe present invention;

FIG. 6 is an exploded view of an embodiment of a location board of thepresent invention;

FIG. 7 is a perspective view of an embodiment of an optic system of thepresent invention;

FIG. 8 is an elevational cutaway view of a distal tip of an embodimentof the catheter of the present invention;

FIG. 9 is a perspective view of an embodiment of an optical cleaningsystem of the present invention;

FIG. 10 is a perspective cutaway view of a distal tip of an embodimentof the catheter of the present invention;

FIG. 11 is a perspective view of a distal tip of an embodiment of thecatheter of the present invention;

FIG. 12 is a plan view of an embodiment of a tool of the presentinvention;

FIG. 13 is a plan view of an embodiment of a tool of the presentinvention within an embodiment of a catheter of the present invention;

FIG. 14 is a plan view of an embodiment of a tool of the presentinvention within an embodiment of a catheter of the present invention;

FIG. 15 is a cutaway perspective view of an embodiment of a distal tipof a catheter of the present invention;

FIG. 16 is a perspective view of an embodiment of a steering system ofthe present invention;

FIG. 17 is a perspective view of an embodiment of a distal tip of acatheter of the present invention;

FIG. 18 is a see-through view of an embodiment of a distal tip of acatheter of the present invention;

FIG. 19 is a close up of a portion of the distal tip of the cathetershown in FIG. 18;

FIG. 20 is a close up of a portion of an embodiment of a distal tip of acatheter of the present invention;

FIG. 21 is a comparison of the bending radius of two catheters havingdifferent rigid tip lengths;

FIG. 22 is an elevation view of several embodiments of distal tips ofcatheters of the present invention juxtaposed to compare sizes;

FIG. 23 is an end view of several embodiments of distal tips ofcatheters of the present invention juxtaposed to compare sizes;

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, there is shown a general embodiment of thecatheter 10 of the present invention. The embodiment in FIG. 1 isdescribed as “general” because it is being used as a platform tointroduce the various aspects and components of the present invention,which will then be discussed separately in more detail. Hence, FIG. 1shows that the catheter 10 is sized to extend from the distal end of aworking channel of a standard bronchoscope A. For example, some commonbronchoscopes have working channels with an internal diameter of about2.8 mm, while others have working channels with an internal diameter ofabout 2.65 mm. Hence, the catheter 10 has an outside diameter of 2.8 mm,or slightly less, or preferably 2.65 mm, or slightly less, such that isslides freely within the working channels of these bronchoscopes A. Thecatheter 10 generally includes a working channel 20, a location system100 (only a component of which is shown in FIG. 1), an optical system200, an optic cleaning system 300, a tool 400, a steering mechanism 500,and a catheter body 600. It is to be understood that the catheter 10 ofthe present invention is considered to be any device containing one ormore of these features, in any of their respective variations discussedbelow, in any combination. These components are being describedindividually specifically so as not to limit the scope of the presentinvention to one or more combinations of these features. One skilled inthe art will quickly realize that the number of components of thecatheter 10, each described in various forms below, would result in toomany combinations to practically describe individually.

Location System 100

The location system 100, shown in FIGS. 2-X, generally includes a sensorassembly 120, a location board 140, and a control system 180.

The sensor assembly 120 may be passive or active. A system using apassive sensor assembly 120 is shown in FIGS. 2-6 and also in U.S.patent application Ser. No. 12/417,381 filed Apr. 2, 2009 entitledMagnetic Interference Detection System and Method, which claims priorityto provisional application Ser. Nos. 61/042,191, filed Apr. 3, 2008, and61/042,578, filed Apr. 4, 2008 entitled Magnetic Interference DetectionSystem and Method, all of which are incorporated by reference herein intheir entireties. The sensor assembly 120 of the passive system is areceiver that generally includes a plurality of (preferably three) fieldcomponent sensors 122, 124 and 126. Each of the field sensor componentsis arranged for sensing a different component of an electromagneticfield generated by the location board 140. Alternatively, the fieldsensor components could use ultrasound technology, or a combination ofelectromagnetic and ultrasound technologies.

In one embodiment, shown in FIGS. 2 and 3, each field component sensor122, 124 and 126 includes two sensor elements, 122 a, 122 b, 124 a, 124b, 126 a, and 126 b, respectively. Typically, the sensor elements arecoils of wire, and the sensed components are independent magnetic fieldcomponents. The coils may be formed by wrapping wire around a core. Thecore may then be removed to form an air core at the center of the coilor may be left in place, forming a solid core coil. Preferably, thesolid core coils are made of a material such as ferrite or anothermaterial having similar magnetic properties.

Preferably, the sensor elements 122, 124 and 126 are arranged in thelocatable guide 120 such that the sensor elements 122 a and 122 b are onopposite sides of, and equidistant from, a common reference point 128.Similarly, sensor elements 124 a and 124 b are on opposite sides of, andequidistant from, point 128, and sensor elements 126 a and 126 b alsoare on opposite sides of, and equidistant from, point 128. In theillustrated example, the sensors 122, 124 and 126 are disposedcollinearly along a longitudinal axis 130 of the sensor assembly 120,but other configurations are possible.

For example, FIG. 4 shows a sensor assembly 120 having field sensorcomponents 122, 124 and 126′. Field sensor components 122 and 124 eachhave two sensor elements 122 a and 122 b, and 124 a and 124 b,respectively. Sensor elements 122 a and 122 b are on opposite sides of,and equidistant from, point 128. Sensor elements 124 a and 124 b are onopposite sides of, and equidistant from, point 128. However, fieldsensor component 126′ consists of a single coil centered on point 128.

FIG. 5 shows an embodiment wherein the field sensor components 122, 124and 126 each include two sensor elements 122 c and 122 d, 124 c and 124d, and 126 c and 126 d, respectively. Each sensor element is a flatrectangular coil, of many turns of conducting wire that is bent into anarcuate shape to conform to the shape of the cylindrical surface. Thedashed lines 134 and dashed circles 136 in FIG. 5 denote a conceptualcylindrical surface. The sensor elements 122 c, 124 c and 126 c areinterleaved around circle 136 a. The sensor elements 122 d, 124 d, and126 d are interleaved around circle 136 b. The sensor elements 122 c and122 d are preferably disposed symmetrically with respect to thereference point 128, meaning that sensor elements 122 c and 122 d are onopposite side of reference point 128, are equidistant from referencepoint 128 and are oriented so that an appropriate 180 degree rotationabout point 128 maps sensor 122 c into sensor 122 d. Similarly, sensorelements 124 c and 124 d are disposed symmetrically with respect toreference point 128, and sensor elements 126 c and 126 d are disposedsymmetrically with respect to reference point 128.

Referring again to FIG. 2, the location system 100 also includes thelocation board 140. The location board 140 is a transmitter ofelectromagnetic radiation. The location board 140 includes a stack ofthree substantially planar rectangular loop antennas 142, 144 and 146connected to drive circuitry 148. FIG. 6 provides an expanded view ofthe loop antennas 142, 144 and 146 of the location board 140 in anexpanded view to show the details of their configurations.

Antenna 142 is skewed in a y direction in that the loops on one side ofthe antenna 142 are closer together than the loops on the opposite side.Hence, antenna 142 creates a magnetic field that is stronger on the sidewhere the loops are close together than it is on the opposite side. Bymeasuring the strength of the current induced by the antenna 142 in thesensor assembly 120, it can be determined where the sensor assembly 120is located in a y direction over the antenna 142.

Antenna 144 is similarly skewed but in an x direction. Hence, theantenna 144 also creates a magnetic field that is stronger on the sidewhere the loops are closer together than it is on the opposite side. Bymeasuring the strength of the current induced by the antenna 144 in thesensor assembly 120, it can be determined where the sensor assembly 120is located in an x direction over the antenna 144.

Antenna 146 is not skewed. Rather, it creates a uniform field thatnaturally diminishes in strength in a vertical direction when thelocation board is horizontal. By measuring the strength of the fieldinduced in the sensor assembly 120, it can be determined how far thelocatable guide is located above the antenna 146.

In order to distinguish one magnetic field from another, the fields ofeach antenna 142, 144 and 146 are generated using independentfrequencies. For example, antenna 142 might be supplied with alternatingcurrent oscillating at 2.5 kHz, antenna 144 might be supplied withalternating current oscillating at 3.0 kHz, and antenna 146 might besupplied with alternating current oscillating at 3.5 kHz. Hence, each ofthe field sensors 122, 124, and 126 of the locatable guide will havethree different alternating current signals induced in its coils.

Driving circuitry 148 includes appropriate signal generators andamplifiers for driving each of the loop antennas 142, 144 and 146 attheir corresponding frequencies. The electromagnetic waves generated bythe location board 140 are received by the sensor assembly 120 andconverted into electrical signals that are then sent to the controlsystem 180, shown diagrammatically in FIG. 2.

The control system 180 generally includes reception circuitry 182 thathas appropriate amplifiers and A/D converters. The reception circuitry182 and the driving circuitry 148, which may be considered part of thecontrol system 180, are controlled by a controller/processor 184 thattypically is an appropriately programmed computer. Thecontroller/processor 184 directs the generation of transmitted signalsby driving circuitry 148.

A location system 100 using an active sensor assembly 120 is shown anddescribed in U.S. Pat. No. 6,188,355 to Gilboa, entitled WirelessSix-Degree-of-Freedom Locator. The entirety of the patent isincorporated by reference herein. The principles of operation aresimilar to the operation of the passive sensor assembly system exceptthat electrical current is sent to the sensor assembly 120, such thatmagnetic fields are generated thereby. These magnetic fields are thendetected by other sensors and that information is used to determine alocation of the probe in which the sensor assembly 120 is located.

Optic System 200

Referring to FIGS. 7 and 8, the optic system 200 generally includes anobjective lens 210 and one or more light sources 220, all preferablycontained under a sealed optic window 240. The optic system 200 mayoperate within or outside of the visible spectrum. As an example only,the optic system 200 may be an infrared system. If an optic cleaningsystem 300, described below, is to be used, it may be preferably to makethe optic window 240 flush with the distal end of the catheter 10,thereby increasing the effectiveness of the cleaning system 300.

If, however, a wide-angle view is desired, there may be utility inproviding a convex optic window 240 that protrudes from the distal tip30 of the catheter 10. This may allow the lens 210 to be closer to, orbeyond the distal tip 30 of the catheter body.

The objective lens 210 may be borrowed from existing technology such asa CMOS, fiberscope or a microvideo system. The lens 210 may also be ahybrid between fiberscope and video technology, such as that found onthe Olympus BF type XP160F, also marketed as the Evis ExeraBronchofibervideoscope (hereinafter “Olympus scope”).

The Olympus scope includes a 1.2 mm working channel for a tool but,unlike the present invention, does not have an optical cleaning system,does not have a location system, and does not fit within a 2.65 mmworking channel. The Olympus scope has an outside diameter of 2.8 mm.

Nevertheless, the lens system of the Olympus scope may have applicationin the catheter of the present invention. The Olympus scope uses asingle, relatively large, light source. The present invention provides aplurality of individual, very small fibers, each acting as light guides220 to illuminate the target. By providing a plurality of small lightsources 220, rather than one larger light source, more space-savingoptions become available and it is possible to reduce the overalldiameter of the catheter 10.

The light fibers 220 terminate at a floor 230 of the optic system 200. Aspace between the floor 230 and the optic window 240 provides room foradditional components 250 and also results in an internal sidewall 260surrounding the floor 230. In one embodiment, this sidewall includes areflective material, which acts to maximize the amount of light beingtransmitted through the optic window 240.

As best seen in FIG. 8, the optic system 200 has a relatively shortaxial length. This leaves room immediately below (proximal) the opticsystem 200 for the sensor assembly 100. The light fibers 220 have roomaround the outside of the sensor assembly 100 to travel the length ofthe catheter for connection to a light source (not shown).

Optic Cleaning System 300

The optic cleaning system 300 is shown generally in FIG. 9. The opticcleaning system 300 includes a nozzle 310 located at the distal tip 30of the catheter 10 and directed toward the optic window 240. The nozzle310 is supplied via a lumen with a pressurized liquid or gas. The nozzledirects a stream 320 of the pressurized liquid or gas onto the opticwindow 240 in order to mechanically remove and/or chemically cleanmucous, blood, tissue or other debris from the optic window 240. Theliquid or gas may be any liquid or gas that can be absorbed by the lungsor exhaled without harming the patient. Liquids may include water,saline, and the like. Gases may include oxygen, nitrogen, helium, air,and the like.

Preferably, the optic cleaning system 300 is fed by a small supply ofliquid or gas that is located in a portion of the catheter system 10that remains outside of the patient, such as the handle. Similarly,locating the valve associated with the actuating system near the supply,as opposed to near the nozzle 310, will reduce the amount of spaceoccupied by the cleaning system 300. If, on the other hand, space alongthe length of the catheter 10 is in short supply, but there is room fora small reservoir at the tip 30 of the catheter, it is envisioned that areservoir and valve mechanism be located at the tip 30 and electricallycontrolled by a small wire running the length of the catheter 10,obviating the need for a supply lumen.

Tool 400

The catheter 10 includes a working channel 20, preferably having anoutside diameter of about 1.2 mm, that can accommodate a tool 400. Thetool 400 may be any endoscopic tool, such as forceps, graspers, brushes,markers, seeds, ablation tools, and the like. By way of example only,several embodiments of a tool 400 are discussed in greater detailherein.

Referring now to FIGS. 10-14, there is shown a needle embodiment of thetool 400. This tool 400 includes a needle tip 410 attached to the distalend of a flexible tube 420. The flexible tube 420 may then be attachedto the distal end of a larger flexible tube 430. This arrangementcreates a shoulder 440 between the tubes 420 and 430, which can be usedas a stop that limits the extent to which the needle tip 410 may beextended from the distal end of the catheter 10.

The example shown in FIG. 12 includes a needle tip 410, which is a 20gauge needle having an outside diameter of approximately 0.9 mm. Thelength of the needle tip 410 is approximately 19 mm. It is understoodthat the length of the needle tip 410 should be selected considering thetask the needle tip 410 is to be given as well as the target location.Because the needle is generally inflexible, a longer needle tip 410 willresult in a longer inflexible tip portion 30 of the catheter 10, whichin turn hampers the navigability of the catheter 10.

The flexible tube 420 may be made of any suitable, biocompatiblematerial having a desired amount of flexibility and axial strength. Amaterial selected for the embodiment of FIG. 12 is transparent nylon.The outside diameter of flexible tube 420 preferably matches the outsidediameter of the needle tip 410. The length of the flexible tube 420 isselected to place the shoulder 440 in a desired position to interactwith a stop 450 (FIGS. 13 and 14) and result in a desired maximumextension length of the needle tip 410. It is envisioned that theflexible tube 420 may have a friction fit with the larger flexible tube430 such that the effective length of the flexible tube 420 may beadjusted for a given procedure by sliding the flexible tube 430 into orout of the larger flexible tube 430 prior to the procedure.

The larger flexible tube 430 of this embodiment is a PEEK tube with anoutside diameter of 1.15 mm and extends to the handle of thebronchoscope. The difference in outside diameter of the flexible tube420 (in this example, 0.9 mm) and the outside diameter of the largertube 430 (in this example, 1.15 mm) results in the shoulder 440. Hence,in this example, the shoulder 440 has a height of 0.125 mm.

FIGS. 13 and 14 show the tool 400 in retracted and extended positions,respectively. In the retracted position of FIG. 13, the needle tip 410is completely contained within the working channel 20 of the catheter10. A separation exists between the shoulder 430 and a needle stop 450within the working channel 20.

In the extended position of FIG. 14, the needle tip 410 protrudes beyondthe distal tip 30 of the catheter 10. The shoulder 440 abuts against thestop 450, thereby preventing the needle 410 from being extended further.

Needle uses are known in the art and are applicable to the needle 410 ofthe present invention. For example, the needle tip 410, the flexibletube 420 and the larger flexible tube 430 all have a central lumen whichcan be made to create one continuous lumen 460 throughout the tool 400.This lumen 460 can be used to apply suction to the tool 400, therebycreating an aspirating needle or a biopsy needle. The lumen 460 can alsobe used as an irrigation port or a means for injecting substances intothe target. Alternatively, as shown in FIG. 11, a separate irrigationlumen 490 can be provided in catheter 10 to be used in conjunction withaspirating suction applied to the tool 400.

If the needle 410 is to be used for biopsy purposes, one skilled in theart will realize that it may be desirable to keep the tissue samplecontained within a distal section of the needle 410 for easy retrievalof the sample after the procedure. In this case the needle lumen 460 maybe larger than a suction lumen 470, as seen in FIG. 11. Hence, a stop480 is created that prevents the tissue from traveling too far into thecatheter 10.

One embodiment of the present invention uses a needle tip 410 or othersuitable delivery device to inject one or more markers into the targetsite. Markers, such as gold markers, can be used as fiducials in animage-guided radiosurgery treatment during interstitial radiation. Theinsertion of internal fiducial markers into various organs assists inprecise setup and real-time tumor tracking during radiotherapy. Markersmay also be used to adjust the center of mass of the target volume to aplanned position for an upcoming treatment. The markers are visible onx-ray, CT, MR, or other imaging technique and a device that deliversexternal beam radiation therapy can use the markers to plan and localizeradiation delivery. The detection of fiducial gold markers is usefulduring automatic on-line megavoltage position verification using amarker extraction kernel (MEK). The markers allow for accurate tumorlocation three-dimensionally throughout the treatment. Alternatively, itis envisioned that the lumen 460 may be used with a pusher to deliverthe markers.

Similarly, the needle 410 can be used to implant seeds forbrachytherapy, as one skilled in the art will realize. The addednavigation accuracy of the catheter 10 made possible by the combinationof the location system 100 and the optic system 200 makes the catheter10 an ideal vehicle for the precise delivery of brachytherapy seeds.

Positive results have been obtained using a needle 410 that is an NMPEneedle with a three-sided Trocar stylet. This particular needle 410 wasmade with 18-gauge thin-walled tubing and has an echogenically enhancedtip for use in combination with ultrasonically guided implants. Theneedle 410 also has an outer cannula chamber for smooth transition.

Existing seed implant needles may also be used in combination with thepresent invention. One example of an existing seed implant needle is theBard BrachyStar® Needle.

Steering System 500

The steering system 500 may utilize any combination of retractable wiresand/or pre-formed bends. One embodiment of a steering mechanism 500 isshown on the catheter tip 30 of FIG. 15. Represented is a cross-sectionof the distal end of a catheter 10. The steering mechanism 500 includesa distal housing 510 that contains the location system 100, defines thedistal end of the working channel 20, and seals the end of the catheter10. The distal housing 510 also defines one or more (in this case four)steering wire lumens 520 for receiving steering wires 530. The steeringwire lumens 520 extend the length of the catheter 10 but the portions ofthe lumens 520 defined by the distal housing 510 are slightly larger toaccommodate an anchor ball 540 at the distal ends of the steering wires530. At a proximal end of the lumen 520, the diameter narrows to that ofthe steering wire 530, thereby creating a shoulder 550 against which theanchor ball 540 acts when pulled.

FIGS. 16-19 show a variation on the design of FIG. 15 in which threesteering wires 530 are used instead of four. As seen in FIG. 17, thesteering mechanism 500 extends from the proximal side of the cathetertip 30 and includes three steering wires 530 spaced 120 degrees apart.

As shown in FIGS. 17-19, rather than extending the steering wire lumens520 to the distal end of the catheter tip 30, access ports 525 areprovided such that the steering wires 530 may be routed into the sidesof the catheter tip 30 and down to the proximal end of the catheter 10.

FIG. 20 shows another embodiment of a steering system 500 of the presentinvention. Here, a manifold 560 is provided that separates the cathetertip 30 from the rest of the catheter 10. The manifold 560 includeschannels 570 that route a steering wire 530 around the periphery of thedisk 560 and back toward the proximal end of the catheter. Thus, onesteering wire 530 becomes looped and effectively becomes two steeringwires.

Examples of other steering mechanisms that may be used with the catheter10 of the present invention include, but are not limited to, thosediscussed in U.S. Pat. No. 6,702,780 to Gilboa et al.

Catheter Design

The catheter body 600 is flexible and carries all of the lumens,steering wires, tools, etc. that are employed by the various tip 30designs of the present invention. Hence, this section will largelyconsist of a discussion of the various arrangements envisioned by thepresent invention. Common to all embodiments, is that the body 600 ispreferably sized to fit within the working channel of a typicalbronchoscope. Notably, however, the minimum bending radius of the body600, while inside the working channel of the bronchoscope, isadvantageously reduced by a reduced tip 30 length, as shown in FIG. 21.

More specifically, FIG. 21 shows a comparison between a prior artcatheter 1 with a longer tip 2 and a catheter 10 of the presentinvention with a shorter tip 30. Both catheters 1 and 10 have the samediameter and are contained within identical working channels 3. Thebending radius is limited by the length of the non-flexible tips 2 and30. A shorter tip 30 allows a tighter bending radius.

Several examples of different configurations of catheters 10 of thepresent invention are shown in FIGS. 22-23. The configurations arejuxtaposed adjacent a prior art catheter 1 to show differences in sizes.FIG. 22 shows elevations of the various catheters while FIG. 23 showscorresponding end views of the distal tips.

The prior art catheter 1 has a tip 2 attached to a flexible, steerablesegment 4. The tip 2 is 10.2 mm long and has a diameter that is lessthan 2.65 mm. However, the location sensor 100 occupies substantiallyall of the tip 2.

Configuration 700 includes a tip 702 attached to a flexible, steerablesegment 704. The tip 702 contains a 19 Ga needle 400, a sensor 100 andtwo irrigation lumens 490, one for irrigation fluid supply and one forapplying suction. The tip 702 is 6.8 mm long and the flexible, steerablesegment 704 is constructed of a flexible material such as nylon.

Configuration 710 includes a tip 712 attached to a flexible, steerablesegment 714. The tip 712 contains a 1.2 mm working channel, a sensor100, and two looped steering wires 530. The tip 712 is 6.4 mm long andthe flexible, steerable segment 714 is constructed of transparentflexible nylon.

Configuration 720 includes a tip 722 attached to a flexible, steerablesegment 724. The tip 722 contains a 1.2 mm working channel, a sensor100, and four steering wires 530. The tip 722 is 6.4 mm long and theflexible, steerable segment 724 is constructed of transparent flexiblenylon.

Configuration 730 includes a tip 732 attached to a flexible, steerablesegment 734. The tip 732 contains a 1.2 mm working channel and a sensor100, and four access ports 525 containing the distal ends of foursteering wires 530. The tip 722 is 6.4 mm long and the flexible,steerable segment 724 is constructed of transparent flexible nylon.

Configuration 740 includes a tip 742 attached to a flexible, steerablesegment 744. The tip 742 contains a 1.2 mm working channel with a needle400 contained therein, a sensor 100, and four access ports 525containing the distal ends of four steering wires 530. The tip 722 is6.4 mm long and the flexible, steerable segment 724 is constructed of aflexible spring segment.

Configuration 750 includes a tip 752 attached to a flexible, steerablesegment 754. The tip 752 contains a 1.2 mm working channel, a sensor100, four access ports 525 containing the distal ends of four steeringwires 530, an irrigation lumen 490, an optic system 200, and an opticcleaning system 300. The tip 752 is 8.5 mm long to accommodate the opticsystem 200 and the flexible, steerable segment 754 is constructed of aflexible material such as nylon.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

We claim:
 1. An apparatus for use in a surgical procedure, comprising; acatheter configured to be received within a working channel of abronchoscope, the catheter having a tool lumen configured to receive atool therethrough to treat target tissue; a navigation systempermanently disposed within the catheter; and an optic systempermanently disposed within the catheter.
 2. The catheter according toclaim 1, wherein the navigation system comprises an electromagneticnavigation system.
 3. The catheter according to claim 1, wherein theoptic system includes a floor and a plurality of individual light fibersterminating at the floor, the floor located at a distal end portion ofthe catheter.
 4. The catheter according to claim 3, wherein the opticsystem includes a window at a distal end of the catheter, the floorbeing longitudinal spaced from the window.
 5. The catheter according toclaim 4, wherein the optic system includes an internal side wallsurrounding the floor and extending from the floor to the window, theinternal side wall including a reflective material configured tomaximize the amount of light transmitted through the window from theplurality of individual light fibers.
 6. The catheter according to claim3, wherein the plurality of individual light fibers terminates along aperimeter of the floor.
 7. The catheter according to claim 3, whereinthe optic system defines a short axial length relative to the length ofthe catheter.
 8. The catheter according to claim 3, wherein theelectromagnetic navigation system is located immediately proximal to thefloor of the optical system.
 9. The catheter according to claim 8,wherein the plurality of individual light fibers extends around theoutside of the electromagnetic navigation system.
 10. A catheter for usein a surgical procedure, comprising: a catheter configured to bereceived within a working channel of a bronchoscope, the catheter havinga tool lumen configured to receive a tool therethrough to treat targettissue; a navigation system permanently disposed within the catheter;and an optic system permanently disposed within the catheter, whereinthe navigation system including sensor elements having an arcuate shape,the sensor elements configured to conform to a cylindrical surface ofthe catheter such that the sensor elements circumscribe the tool lumen.11. The catheter according to claim 10, wherein the navigation systemcomprises an electromagnetic navigation system.
 12. The catheteraccording to claim 10, wherein the optic system includes a floor and aplurality of individual light fibers terminating at the floor, the floorlocated at a distal end portion of the catheter.
 13. The catheteraccording to claim 12, wherein the optic system includes a window at adistal end of the catheter, the floor being longitudinal spaced from thewindow.
 14. The catheter according to claim 13, wherein the optic systemincludes an internal side wall surrounding the floor and extending fromthe floor to the window, the internal side wall including a reflectivematerial configured to maximize the amount of light transmitted throughthe window from the plurality of individual light fibers.
 15. Thecatheter according to claim 12, wherein the plurality of individuallight fibers terminates along a perimeter of the floor.
 16. The catheteraccording to claim 12, wherein the optic system defines a short axiallength relative to the length of the catheter.
 17. The catheteraccording to claim 12, wherein the electromagnetic navigation system islocated immediately proximal to the floor of the optical system.
 18. Thecatheter according to claim 17, wherein the plurality of individuallight fibers extends around the outside of the electromagneticnavigation system.